Stock Movers on FDA Decision (CELG, CLDX, GILD)

Celgene Corporation (NASDAQ:CELG) rose 0.55% to $53.32 on heavy volume after the company has received a Paragraph IV Certification Letter advising that Natco Pharma Limited of Hyderabad, India, submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration requesting the authorization to manufacture and market generic versions of REVLIMID. Natco Pharma is aiming to produce the 5, 10, 15 and 25 mg capsule doses.

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Celgene Corporation is an integrated biopharmaceutical company primarily engaged in the discovery, development and commercialization of therapies designed to treat cancer and immune-inflammatory related diseases.

Celldex Therapeutics, Inc. (NASDAQ:CLDX) plunged 34% to $3.16 on heavy volume after announces that they will regain full worldwide rights to develop and commercialize rindopepimut (CDX-110). The effective date is November 1, 2010.

Pfizer (NYSE: PFE) has informed Celldex that the rindopepimut program is no longer a strategic priority of Pfizer and has terminated the agreement.

Celldex Therapeutics, Inc. (Celldex) is a biopharmaceutical company, which applies its Precision Targeted Immunotherapy Platform to generate a pipeline of candidates to treat cancer and other difficult-to-treat diseases.

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Gilead Sciences, Inc. (NASDAQ:GILD) rose 1% to $33.47 after it announces that they have submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for marketing approval for the fixed-dose combination of Truvada.

An MAA has also been submitted for Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278.

Gilead Sciences, Inc. (Gilead) is a biopharmaceutical company that discovers, develops and commercializes therapeutics. The Company has operations in North America, Europe and Australia. The Company’s products include Truvada, Atripla, Viread, Emtriva, Hepsera, AmBisome, Letairis, Ranexa, Vistide and Cayston. The Company has sales operations, with marketing subsidiaries in Australia.

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